15457758 Jul 3 2007 3:47PM - awp.doj.wi.gov · PDF fileSECOND AMENDED COMPLAINT I....

101
15457758 Jul 3 2007 3:47PM

Transcript of 15457758 Jul 3 2007 3:47PM - awp.doj.wi.gov · PDF fileSECOND AMENDED COMPLAINT I....

15457758

Jul 3 2007 3:47PM

MICHAEL WINGET-HERNANDEZ (TX Bar No. 2176950) 31 12 Windsor Road, Suite 228 Austin, Texas 78703 Telephone: (512) 474-4095 Facsimile: (512) 697-0080 Email: [email protected]

PRICE, OKAMOTO, HIMENO & LUM WARREN PRICE, Ill 1212 KENNETH T. OKAMOTO 2068 RICK J. EICHOR 1588 707 Richards Street, Suite 728 Honolulu, Hawaii 96813 Telephone: (808) 538-1 113 Facsimile: (808) 533-0549 E-mail: [email protected] E-mail: [email protected] E-mail: [email protected]

ATTORNEYS FOR PLAINTIFF

IN THE CIRCUIT COURT OF THE FIRST CIRCUIT

STATE OF HAWAI'I

State of Hawaii,

Plaintiff,

VS.

Abbott Laboratories Inc.; Alpharma USPD, Inc.; Apothecon, Inc.; AstraZeneca Pharmaceuticals LP, AstraZeneca LP; Aventis Pharmaceuticals, Inc.; Aventis Behring LLC nlkfa ZLB Behring LLC; Barr Laboratories, Inc.; Baxter Healthcare Corporation; Ben Venue Laboratories, Inc.; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer lngelheim Roxane, Inc. WMa Roxane Laboratories, Inc.; Bristol- Myers Squibb Co.; Centocor, Inc.; Dey, Inc.; Forest Pharmaceuticals, Inc.; SmithKline Beecham Corporation d/b/a GlaxoSmithKline; Hoffman-LaRoche, Inc.;

Civil No. 06-1-0720-04 EEH (Complex Litigation)

SECOND AMENDED COMPLAINT; EXHIBITS "1 to 3 ; SUMMONS TO ANSWER SECOND AMENDED COMPLAINT; DEMAND FOR JURY TRIAL; CERTIFICATE OF SERVICE

Hospira, Inc.; lvax Corporation; lvax . .

Pharmaceuticals Inc.; Janssen, LP f/k/a Janssen Pharmaceutica, LP; Johnson & Johnson, Inc.; McNeil-PPC, Inc.; Merck & Co., Inc.; Mylan Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Ortho Biotech Products, LP; Par Pharmaceutical Cos., Inc.; Pfizer, Inc.; Pharmacia Corporation; Purepac Pharmaceutical Co.; Roche Laboratories, Inc.; Sandoz, Inc.; Schering-Plough Corporation; Sicor Pharmaceuticals, Inc. f/Wa Gensia Sicor Pharmaceuticals, Inc.; TAP Pharmaceutical Products, Inc.; Teva Pharmaceuticals USA, Inc.; Warrick Pharmaceuticals Corporation; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc., f/k/a Schein Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Doe Corporations 1-100; Doe Entities 1-100.

Defendants.

VII .

VIII .

TABLE OF CONTENTS

INTRODUCTION ........ ... .................................................................................. I

PARTIES .............................................................................................................. 2

A . Plaintiff ........................................................................................................ 2

B . Defendants .......... .................... .................................................................... 3

FACTUAL BACKGROUND ................................................................................ I 0

A . The Market for Prescription Drugs ............................................................ 10

B . The Purpose of the Medicaid Program and How it ..................................... Responds to the Complexity of the Drug Markets 12

............... C . Defendant's Corruption of the Government Medicaid Programs 15

DEFENDANTS' EXACERBATION OF THE COMPLEXITIES OF THE MARKET AND AFFIRMATIVE CONCEALMENT OF THEIR WRONGDOING ................................................... 18

THE GOVERNMENTAL INVESTIGATIONS OF DEFENDANTS' CONDUCT ......................................................................................................... 22

THE INJURY TO GOVERNMENTAL HEALTH PLANS ........................... CAUSED BY DEFENDANTS' FALSE WHOLESALE PRICES 26

A . The Hawaii Medicaid Program .................................................................. 26

B . The Medicare Program .................... .. .................................................. 28

DEFENDANTS' CONDUCT INTENTIONALLY DISREGARDED ESTABLISHED LAW .......................... .. .............................. 30

TOLLING ............................................................................................................ 30

Count I - False Claims ....................................................................................... 31 Count II - Unfair or Deceptive Acts or Practices ............................................... 31 . . Count Ill - Unfair Compet~tron ............................................................................ 32 Count IV - Deceptive Trade Practices Act ......................................................... 32 Count V - Intentional and / or Negligent Misrepresentation ...................... ..... 33 Count VI - Unjust Enrichment ............................................................................ 33

SECOND AMENDED COMPLAINT

I. INTRODUCTION

1. This case is an enforcement action brought by the State of Hawaii under

State law on behalf of its Medicaid program, as well as Hawaii residents who are

Medicare beneficiaries, against Defendant Drug Companies who have caused the

submission of false claims and engaged in unfair or deceptive acts or practices in the

sale, pricing and marketing of their prescription drug products. The State of Hawaii

brings this action exclusively under the common law and statutes of the State of Hawaii.

No federal claims are asserted. No aspect of the claims asserted herein is brought

pursuant to any federal law, including either Medicare or ERISA, nor is any aspect of the

claims asserted herein brought for the purpose of interpreting a federal contract or the

terms of an ERISA plan.

2. The Defendant Drug Companies' fraudulent pricing and marketing of their

prescription drugs have impacted elderly, disabled, and poor Hawaii citizens covered by

Medicaid and Medicare by causing them to pay grossly excessive prices for the

Defendants' prescription drugs. Defendants have taken advantage of the enormously

complicated and non-transparent market for prescription drugs to engage in an unlawful

scheme to cause Hawaii and its citizens to pay inflated prices for prescription drugs. The

scheme involves the publication by Defendants of phony "average wholesale prices,"

which become the basis for calculating the cost at which "providers" -the physicians,

clinics, and pharmacies who provide these prescription drugs to patients - are reimbursed

by Plaintiff. Defendants reinforce this basic tactic with other deceptive practices described

in this Second Amended Complaint, including the use of secret discounts and rebates to

providers and the use of various devices to keep secret the prices at which their drugs are

currently available in the marketplace to other purchasers. By willfully engaging in this

scheme, Defendants have succeeded in having Plaintiff finance windfall profits to these

providers. Defendants attempt to profit from their scheme by using the lure of these

windfall profits competitively to encourage providers to buy their drugs instead of

competing in the marketplace solely on the basis of legitimate factors such as price and

the medicinal value of their drugs.

3. Fair and honest drug pricing is a matter of great importance to the State

and its citizens. Expenditures by the State and its agencies for prescription drug

reimbursement have increased dramatically in the past several years as a result, in part,

of Defendants' fraudulent pricing scheme. Each year Hawaii spends millions of dollars

on prescription drugs under the Hawaii Medicaid program. The cost of prescription drug

services in the Hawaii Medicaid program has seen dramatic increases rising from $25.4

million in 1997 to $1 17 million in 2004, an increase of over 350%.

4. This exponential increase in prescription drug costs in recent years has

contributed to a health care funding crisis within the State that requires action to ensure

fair dealing between the Defendants and the State and Hawaii Medicare beneficiaries.

II. PARTIES

A. Plaintiff

5. This action is brought by the State of Hawaii for violations of 1) the Hawaii

False Claims Act, Unfair Competition, Deceptive Trade Practices, Non-Disclosure, and

Unjust Enrichment, and 2) as parens patriae on behalf of Medicare beneficiary

purchasers for Unfair or Deceptive Acts or Practices andlor Unfair Competition,

Deceptive Trade Practices, declared unlawful by Hawaii Revised Statutes ("H.R.S.")

s480-2, H.R.S. $480-13 and H.R.S. 481A-3(a)(9), (11) and (12) and Unjust

Enrichment. No claim is asserted for Medicare beneficiaries who made flat insurance

co-payments and those whose co-payment was reimbursed in full by a third-party

insurer.

6. The Attorney General is authorized to bring this action on behalf of the

State of Hawaii and its agencies by virtue of H.R.S. 528-1. The Attorney General is

authorized to bring this case for indirect purchasers based upon unfair or deceptive acts

or practices andlor unfair competition declared unlawful by H.R.S. $480-2 by virtue of

H.R.S. s480-14.

B. Defendants

7. Defendants are all pharmaceutical companies whose fraudulent schemes,

including the publication of excessive and inflated prices for prescription drugs, as

described in this Second Amended Complaint, have caused to be presented to officers

andlor employees of the State of Hawaii false or fraudulent claims for payment or

approval of certain drugs to get these false or fraudulent claims paid or approved by the

State of Hawaii Medicaid program, and have resulted in Hawaii and its citizens paying

for drugs at inflated prices, as detailed below.

8. At all times material to this civil action, each Defendant has transacted

business in the State of Hawaii by, including but not limited to, selling directly or through

wholesalers its drugs, including those identified in this Second Amended Complaint, to

purchasers within the State of Hawaii.

9. ~efendant Abbott Laboratories Inc. ("Abbott") is a Delaware corporation

with its principal place of business located at 100 Abbott Park Road, Abbott Park, IL

60064-6400.

10. The following two Defendants are hereinafter referred to as the Alpharma

group:

(a) Defendant Alpharma USPD, Inc. ("Alpharma") is a Delaware corporation in the business of manufacturing and selling pharmaceuticals Alpharma's principal place of business is located at One Executive Drive, Ft. Lee, NJ 07024; and

(b) Defendant Purepac Pharmaceutical Co. ("Purepac") is a Delaware corporation in the business of manufacturing and selling pharmaceuticals. Purepac's principal place of business is located at 14 Commerce Drive, Suite 301, Cranford, NJ 07016. Purepac is a wholly owned subsidiary of Alpharma, Inc.

11. Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP

("AstraZeneca") are related Delaware corporations with their principal place of business

located at 1800 Concord Pike, Wilmington, DE 19850.

12. The following two Defendants are referred to as the Aventis group:

(a) Defendant Aventis Pharmaceuticals, Inc. is a Delaware corporation with its principal place of business is located at 300-400 Somerset Corporate Boulevard, Bridgewater, NJ 08807-2854; and

(b) Defendant Aventis Behring, LLC n/Ma ZLB Behring LLC is headquartered at 1020 First Avenue, King of Prussia, PA 19406-2854.

13. Defendant Barr Laboratories, Inc. ("Barr") is a Delaware corporation with

its principal place of business located at 400 Chestnut Ridge Road, Woodcliff Lake, NJ

14. Defendant Baxter Healthcare Corporation ("Baxter") is a Delaware

corporation with its principal place of business located at One Baxter Parkway,

Deerfield, lL 60015.

15. The following three Defendants are hereinafter referred to as the

Boehringer group:

(a) Defendant Boehringer lngelheim Pharmaceuticals, Inc. ("Boehringer Pharm"), a wholly owned subsidiary of Boehringer lngelheim Corp. ("Boehringer"), is a Connecticut corporation engaged in the business of manufacturing and selling pharmaceuticals. Boehringer Pharm's principal place of business is located at 900 Ridgebuy Road, Ridgefield, CT 06877; and

(b) Defendant Boehringer lngelheim Roxane, Inc. ("BIRI"), f/k/a Roxanne Laboratories, Inc., a wholly-owned subsidiary of Boehringer, is a Delaware corporation engaged in the business of manufacturing and selling pharmaceuticals. BIRl's principal place of business is located at 1809 Wilson Road, Columbus, OH 43216-6532; and

(c) Defendant Ben Venue Laboratories, Inc. ("Ben Vue") is a wholly owned subsidiarv of Boehrinaer lnaelheim Comoration and is a Delaware corporation engaged in the business of manufacturing and selling pharmaceuticals. Ben Venue's principal place of business is located at 300 ~.

Northfield Road, Bedford, OH 44146. Ben Venue is also being sued for the conduct of its subsidiaries andlor divisions, including but not limited to Bedford Laboratories.

16. Defendant Bristol-Myers Squibb Co. ("Bristol-Myers") is a Delaware

corporation engaged in the business of manufacturing and selling pharmaceuticals.

Bristol-Myers' principal place of business is located at 345 Park Avenue, New York, NY

10154-0037. Bristol-Myers is also being sued for the conduct of its subsidiaries andlor

divisions, including but not limited to E.R. Squibb & Sons, Inc. and Apothecon, lnc

17. Defendant Dey, Inc. ("Dey") is a Delaware corporation with its principal

place of business located at 2751 Napa Valley Corporate Drive, Napa, CA 94558,

18. Defendant Forest Pharmaceuticals, Inc. ("Forest") is a Delaware

corporation engaged in the business of manufacturing and selling pharmaceuticals.

Forest's principal place of business is located at 909 Third Avenue, New York, NY

19. Defendant SmithKline Beecham Corporation dlbla GlaxoSmithKline

("GlaxoSmithKline"), is a Delaware corporation with its principal place of business

located at One Franklin Plaza, Philadelphia, PA 19102.

20. Defendant Hoffman-LaRoche, Inc. ("Hoffman-LaRoche") is a New Jersey

corporation with its principal place of business located at 340 Kingsland Street, Nutley,

NJ 07110-1 199. Hoffman LaRoche is also being sued for the conduct of its subsidiaries

andlor divisions, including but not limited to Roche Laboratories, Inc.

21. Defendant Hospira, Inc. ("Hospira") is a corporation organized under the

laws of Delaware, with its principal offices located at 275 N. Field Drive, Lake Forest, IL.

60045, Hospira is the successor to Abbott's Hospital Products Division.

22. The following five Defendants are hereinafter referred to as the Johnson &

Johnson group:

(a) Defendant Johnson & Johnson, Inc. ("J&JU) is a New Jersey corporation engaged in the business of manufacturing and selling pharmaceuticals. J&Js principal place of business is located at One Johnson &Johnson Plaza, New Brunswick, NJ 08933; and

(b) Defendant Janssen, LP flkla Janssen Pharrnaceutica, LP ("Janssen"), a wholly-owned subsidiary of J&J, is a New Jersey limited partnership engaged in the business of manufacturing and selling pharmaceuticals. Janssen's principal place of business is located at 1125 Trenton-Harbourton Road, Titusville, NJ 08560; and

(c) Defendant Ortho Biotech Products, LP ("Ortho Biotech"), a wholly owned subsidiary of J&J, is a New Jersey limited partnership engaged in the business of manufacturing and selling pharmaceuticals. Ortho Biotech's principal place of business is located at 700 U.S. Highway 202, Raritan, NJ 08869; and

(d) Defendant McNeil-PPC, Inc. ("McNeil"), a wholly owned subsidiary of J&J, is a New Jersey corporation engaged in the business of manufacturing and selling pharmaceuticals. McNeil's principal place of business is located at 7050 Camp Hill Road, Ft. Washington, PA 19034. McNeil Consumer & Specialty Pharmaceuticals ("McNeil Cons") is a division of McNeil; and

(e) Defendant Centocor, Inc. ("Centocor") is a wholly owned subsidiary of Defendant Johnson & Johnson with its principal place of business located at 8001850 Ridgeview Drive, Horsham, PA 19044. The principal drug it markets is Remicade for autoimmune conditions.

23. Defendant Merck 8 Co., Inc. ("Merck") is a New Jersey corporation

engaged in the business of manufacturing and selling pharmaceuticals. Merck's

principal place of business is located at One Merck Drive, Whitehouse Station, NJ

24. The following two Defendants are hereinafter referred to as the Mylan

group:

(a) Defendant Mylan Laboratories, Inc. ("Mylan") is a Pennsylvania corporation engaged in the business of manufacturing and selling pharmaceuticals, mainly through its subsidiaries. Mylan's principal place of business is located at 1500 Corporate Drive, Suite 400, Canonsburg, PA 1531 7; and

(b) Defendant Mylan Pharmaceuticals, Inc. ("Mylan Pharm"), a wholly owned subsidiary of Mylan, is a West Virginia corporation engaged in the business of manufacturing and selling pharmaceuticals. Mylan Pharrn's principal place of business is located at 1500 Corporate Drive, Suite 400, Canonsburg, PA 15317.

25. The following two Defendants are hereinafter referred to as the Novartis

group:

(a) Defendant Novartis Pharmaceuticals Corp. ("Novartis") is a New Jersey corporation engaged in the business of manufacturing and selling pharmaceuticals. Novartis' principal place of business is located at One Health Plaza, East Hanover, NJ 07936; and

(b) Defendant Sandoz, Inc. ("Sandoz"), formerly known as Geneva Pharmaceuticals, Inc., is a Delaware corporation engaged in the business of manufacturing and selling pharmaceuticals. Sandoz's principal place of business is located at 506 Carnegie Center, Princeton, NJ 08540.

26. Defendant Par Pharmaceutical Cos., Inc. ("Par") is a Delaware corporation

with its principal place of business located at One Ram Ridge Road, Spring Valley, NY

10977. Par is also being sued for the conduct of its subsidiaries and/or divisions,

including but not limited to Par Pharmaceutical, Inc.

27. Defendant Pfizer, Inc. ("Pfizer") is a Delaware corporation with its principal

place of business located at 235 E. 42nd Street, New York, NY 10017. In April, 2003,

Pfizer acquired Pharmacia Corporation. Pfizer is also being sued for the conduct of its

subsidiaries and/or divisions, including but not limited to Warner-Lambert, Pfizer-

Warner-Lambed, and Parke-Davis.

28. The following two Defendants are hereinafter referred to as the Schering

group:

(a) Defendant Schering-Plough Corp. ("Schering-Plough") is a New Jersey corporation with its principal place of business located at 2000 ~ a l l o p i n ~ Hill Road, ~enilworth, NJ 07033-0530. Schering-Plough has enaaaed in the oractices described in this Second Amended Comolaint unie;its own nsme and through its wholly-owned subsidiary, Wairick Pharmaceutical Industries, Ltd.; and

(b) Defendant Warrick Pharmaceuticals Corporation ("Warrick"), is a Delaware corporation with its principal place of business located at 12125 Moya Boulevard, Reno, NV 89506-2600. Warrick is a wholly owned subsidiary of Defendant Schering-Plough and has been since its formation in 1993. Warrick manufactures generic pharmaceuticals.

29. Defendant TAP Pharmaceutical Products, Inc. ("TAP") is a Delaware

corporation headquartered at Bannackburn Lake Office Plaza, 2355 Waukegan Road,

Deerfield, IL 60015. TAP is jointly owned by Abbott Laboratories and Takeda Chemical

Industries, Ltd.

30. The following four Defendants are referred to as the Teva Group:

(a) Defendant Teva Pharmaceuticals USA, Inc. ("Teva US") is a Delaware corporation engaged in the business of manufacturing and selling pharmaceuticals. Teva's principal place of business is located at 650 Cathill Road, Sellersville, PA 18960. Teva US is a subsidiary of an Israeli corporation, Teva Pharmaceutical Industries, Ltd. ("Teva Ltd."); and

(b) Defendant lvax Corp. ("lvax"), which became a wholly owned subsidiary of Teva Ltd. on January 26, 2006, is a Florida (formerly Delaware) corporation engaged in the business of manufacturing and selling pharmaceuticals. Ivax's principal place of business is located at 4400 Biscayne Boulevard, Miami, FL 33137; and

(c) Defendant lvax Pharmaceuticals Inc. ("lvax Pharm"), a wholly owned subsidiary of lvax, is a Florida corporation engaged in the business of manufacturing and selling pharmaceuticals. lvax Pharm's principal place of business is located at 4400 Biscayne Boulevard, Miami, FL 33137; and

(d) Defendant Sicor Pharmaceuticals, Inc., f/k/a Gensia Sicor Pharmaceuticals, Inc., is a Delaware corporation with its principal place of business located at 19 Hughes, Irvine, CA 92618-1902. Sicor is owned by Teva Ltd.

31. The following three Defendants are hereinafter referred to as the Watson

group:

(a) Defendant Watson Pharmaceuticals, Inc. ("Watson") is a Nevada corporation engaged in the business of manufacturing and selling pharmaceuticals. Watson's principal place of business is located at 31 1 Bonnie Circle, Corona, CA 92880; and

(b) Defendant Watson Pharma, Inc., fMa Schein Pharmaceuticals, Inc. ("Watson Pharma"), a wholly-owned subsidiary of Watson Pharmaceuticals, Inc. since 2000, is a Delaware corporation. Watson Pharma's principal place of business is located at 31 1 Bonnie Circle, Corona, CA 92880; and

(c) Defendant Watson Laboratories, Inc. ("Watson Labs"), a wholly- owned subsidiary of Watson Pharmaceuticals, Inc., is a Nevada corporation with its principal place of business located at 31 1 Bonnie Circle, Corona, CA 92880.

32. This Court has jurisdiction over Plaintiffs claims as they involve claims

arising exclusively under Hawaii statutes and the parens patriae authority of the

Attorney General to act on behalf of the State of Hawaii and its citizens.

Ill. FACTUAL BACKGROUND

A. The Market for Prescription Drugs

33. The market for prescription drugs is extremely complex. It is composed of

over 65,000 separate National Drug Codes ("NDCs") and is non-transparent. (There is a

separate NDC number for each dosage and package size of each drug manufactured by

each manufacturer.) The essential structure of the prescription drug market is as follows:

The drugs themselves are manufactured by enormous and hugely profitable companies

such as Defendants. Defendants sell the drugs (with varying numbers of intermediaries,

primarily wholesalers, involved in the process) to physicians, clinics, and pharmacies.

These physicians, clinics, and pharmacies are called "providers." The providers then in

essence resell the drugs to those requiring them when the drugs are prescribed for,

administered or dispensed to those patients.

34. In the case of Medicare and Medicaid programs, the price that is paid for

the patient's prescribed drug ultimately will be paid in whole or in large part by a

government entity, and in the case of Medicare, the Medicare beneficiary pays a 20

percent co-payment. These entities are known as the "payers" or "third party payers."

In the case of Medicare and Medicaid programs the reimbursement is made directly to

the provider, not to the patient.

35. This market structure means that the prescription drug market differs in

two crucial respects from most markets.

36. First, in most markets, the ultimate consumer determines the product

demand. This is not the case for prescription drugs. In the prescription drug market,

the decision to use a prescription drug is made by the physicians, by the hospitals in

which the patient is treated, home health care agencies, long term care pharmacies or

(with respect to the decision to use generic drugs versus brand-name drugs) a

pharmacy. Since prescription drugs are dispensed only on a physician's order, the

physician has the principal say in what drug will be chosen for the patient. However,

hospitals, particularly teaching hospitals, also have considerable influence over this

choice. If a hospital decides to put one drug as opposed to a competing drug on its

"formulary" (the list of drugs that the hospital pharmacy stocks), the result will be that

the physicians (particularly residents and attending physicians who are employed by the

hospital) will likely order that drug rather than a competing drug. Likewise, although

pharmacists do not prescribe drugs, pharmacists can exert an important influence over

the choice of which drug the patient will purchase where there is a choice between

buying different generic versions of the same drug.

37. A second difference of the prescription drug market from other markets is

that in ordinary markets, the ultimate consumer of the product pays for it directly. In the

prescription drug market, however, most payments are made by "payers" through

private or public insurance programs.

38. The structure of the prescription drug market produces the following

fundamental fact that underlies Defendants' unlawful scheme. If a Defendant Drug

Manufacturer can cause a "payer" to reimburse for the Defendant's drug at a higher

price than the price the provider paid to buy the drug from the Defendant, there will be a

"spread" between the two prices, and that "spread" is retained by the provider as profit.

The larger the "spread" that can be created for a particular drug, the greater the

incentive the provider has for choosing, or for influencing the choice of, that drug rather

than a drug from a competing manufacturer.

B. The Purpose of the Medicaid Program and HOW it Responds to the Complexitv of the Druq Markets

39. The purpose of Hawaii's Medicaid program is to provide medical

assistance to the State's neediest citizens.

40. Hawaii, through its Medicaid program, is a huge purchaser of drugs,

currently purchasing over $1 10 million annually. Although participation by the

Defendants in the Hawaii Medicaid program is purely voluntary, because of the size of

the Hawaii Medicaid program all Defendants have chosen to participate and sell drugs

to Hawaii's Medicaid participants. Thus, Hawaii may at any given'time have to

reimburse a pharmacist for any of the drugs from any of the Defendants-a universe of

many thousands of drugs.

41. Hawaii's task is further complicated in that Federal law places limits on

what Hawaii may pay for any particular drug. According to 42 CFR § 447.331, Hawaii

may reimburse pharmacists at "the lower of the - 1) Estimated acquisition costs plus

reasonable dispensing fees established by the agency; or 2) Providers' usual and

customary charges to the general public." 42 CFR § 447.331. The "estimated

acquisition cost" ("EAC) means the agency's estimate of the price generally and

currently paid by providers for a drug marketed or sold by a particular manufacturer or

labeler in the package size of drug most frequently purchased by providers." 42 CFR fj

447.301. Thus, pursuant to federal law, the highest price Hawaii can pay for a drug is

the estimated acquisition cost of that drug to a provider. Hawaii currently estimates the

EAC as the AWP minus 10.5%.

42. Defendants have hidden the wholesale prices at which they sell their

drugs, and their knowledge about the prices at which wholesalers sell their drugs to

providers, (as described in more detail herein) thus depriving Hawaii of access to the

pricing information it needs to estimate accurately the acquisition cost of Defendants'

drugs. Because neither Hawaii nor any other state has the knowledge base required to

accurately estimate Defendants' drug prices, entire businesses have grown up to

provide pricing information to the states and others. Two of these are of particular

importance in this case. They are First DataBank and the Redbook. These

compendiums purport to supply accurate price information on Defendants' drugs

through information obtained from Defendants themselves

43. Hawaii, as have most other states, has chosen First DataBank as its

primary price source. First DataBank purports to supply the states with accurate

information about the average wholesale price ("AWP) of all drugs that it receives from

the drug manufacturers themselves. As First DataBank explained the concept of the

Average Wholesale Price to its customers in September 1991:

Average Wholesale Price (AWP) is perhaps the most misunderstood concept in the pharmaceutical industry. The purpose of this article is to describe what is meant by AWP and to explain some of the underlying concepts involved in the acquisition, determination and maintenance of First DataBank's AWP.

AWP represents an average price that a wholesaler would charge a pharmacy for a particular product. The operative word is average. AWP never means that every purchase of that product will be exactly at that price. There are many factors involved in pricing at the wholesale level that can modify the prices charged even among a group of customers from the same wholesaler. AWP was developed because there had to be some price that all parties could agree upon if machine processing was to be possible.

At First DataBank, all pricing information is received in hard copy from the manufacturers. Catalogs, price updates, and other information reach us by fax, Federal Express, or U.S. mail. In the past two years, fax transmission has streamlined the acquisition of data to a large extent.

Exhibit 1.

For virtually the entire time period relevant hereto, First DataBank has represented that its

published prices reflect actual average wholesale prices.

44. Because Hawaii, like most states, has no consistent source of systematic

information about providers' acquisition cost for the drugs that it reimburses, Hawaii has

relied on the prices reported to First DataBank by Defendants and published by First

DataBank to estimate the acquisition cost of most of its drugs. Consistent with the

explanation of AWP by First DataBank that some providers pay less than the published

AWP and some more - that the AWP is only an average of wholesale prices - Hawaii

set its reimbursement at AWP minus 10.5% for most of the relevant period. Hawaii also

pays a separate dispensing fee to providers. It has never been Hawaii's intention to pay

more for a drug than the cost of that drug to a provider.

45. As a practical matter, Hawaii, as most other states, is dependent on the

First DataBank pricing reports for the maintenance of its Medicaid claims processing

system. Hawaii contracts with ACS, a company whose business is to electronically

process on a real-time basis the claims for drugs prescribed, or administered to, Hawaii

Medicaid participants. At the time a prescription is presented to a pharmacy, the

pharmacy submits a real-time claim to ACS electronically through what is called a Point-

of-Sale ("POS") claims processing system. Upon receipt, the POS system monitors the

reimbursement claim for eligibility, covered drugs, Medicaid cost containment policies

and pricing. ACS then sends a real time response that includes the authorized

payment. Thereafter ACS sends Remittance and Status Reports ("R&Sn) to Medicaid

certified providers for paid real-time claims.

46. First DataBank sends its updated AWPs for the thousands of NDC codes

listed in its database to ACS on a weekly basis and this information is entered into the

system. These prices become the basis for Hawaii's reimbursements to providers.

There is no other electronic source for this information.

47. Thus, Hawaii is functionally dependent on the accuracy of the data

supplied by First DataBank, and supplied to First DataBank by the Defendants, in

meeting its obligation to pay providers no more than the actual acquisition cost of their

drugs.

C. Defendant's Corruption of the Government Medicaid Proqrarns

48. Defendants have defeated the intent of the Medicaid Program to pay

providers at a rate no greater than their acquisition cost by reporting false and inflated

AWPs to First DataBank and/or by reporting prices which, they knew, because of the

manner of First DataBank's operations, would misrepresent Defendants' true wholesale

prices. One purpose of this scheme was and is to create the spread between the true

wholesale price of a drug and the false and inflated AWP reported by First DataBank

and thereby increase the incentive for providers to choose the drug for their patients, or,

at a minimum, to counteract the same tactic used by a competitor.

49. The higher the spread between the AWP and the wholesale price the

provider actually pays, the more profit a provider can make. Defendants often market

their products by pointing out (explicitly and implicitly) that their drug's spread is higher

than a competing drugs'.

50. One example of how Defendants market this spread is Adriamycin, one of

the drugs used in treating breast cancer. Defendant Pharmacia reported an AWP of

$241.36 for Adriamycin in April 2000 when the drug was actually selling at wholesale for

as low as $33.43, creating a "spread" of $207.93. These spreads were then advertised

to oncology providers in promotions that emphasized a wide margin of profit.

51. All of the Defendants have inflated their reported average wholesale

prices of their drugs and those of their subsidiaries to levels far beyond any real

average wholesale price of their drugs and those of their subsidiaries. One high-ranking

industry executive has described it as the industry practice to do so.

52. In 2004, high-ranking executives of Defendants Roxanne, Dey, Aventis

and Barr testified in Congress that the AWP was not a legitimate price. And, Defendant

Dey's chief financial officer testified before Congress as follows: "Why doesn't Dey

lower its AWP on generic drugs? The simple answer is that given the system that now

exists our customers won't buy from us if we lower our AWP."

53. Dey brought a lawsuit against First DataBank, the publisher of the medical

compendium that Hawaii Medicaid relies on for prescription drug pricing, because it

published the actual average wholesale price of Dey's drugs instead of the false

average wholesale price sent to the publisher by Dey. Dey's principal allegation in that

lawsuit was that the publication of its actual prices for drugs was inconsistent with the

practice in the industry of accepting and publishing reported, inflated AWPs, and that

such publication put Dey at a competitive disadvantage because it had no "spread" to

advertise.

54. Attached as Exhibit 2 to this Second Amended Complaint is a list of drugs

manufactured by the Defendants andlor their subsidiaries that the U.S. Department of

Justice, after an extensive investigation, found to have inflated AWPs. The U.S.

Department of Health and Human Services concluded, with respect to all drugs utilized

in the Medicare Program that "[a] general conclusion reached in reviewing GAO

[General Accounting Office] and OIG [Office of Inspector General] data is that there is a

level of overstatement in the listed AWP for all drugs. . . . ." Payment Reform for Part B

Drugs, 68 Fed. Reg. 50,430 (August 20,2003) (emphasis added).

55. Examples of the Defendants' practices of inflating AWPs include:

56. Plaintiff has secured the false prices Defendants caused to be published

from First DataBank, the business that supplies Hawaii, and most other states, with

pricing information for use in its Medicaid program. Hawaii has also secured data

showing the true average wholesale prices of Defendants' drugs from

AmeriSourceBergen, a major drug wholesaler. (The Defendants have not produced

comprehensive pricing data because discovery is just starting.) Attached as Exhibit 3 is

a chart containing a summary of falsely reported and actual wholesale prices for various

of Defendants drugs. Exhibit 3 compares the false prices published in First DataBank to

ManufacturerlDrug

Baxter Dextrose Ben VenueIBedford Labs Etoposide, 20 ml. PharmacialUpjohn Methylprednisolone Sodium Succinate (Solu- Medrol)

2000 AWP

$542.88

$550.00

$21.90

2000 Available Price

$86.40

$45.13

$5.51

Spread

. $456.48

$504.87

$16.39

% Spread

528%

11 19%

297%

the true average annual wholesale prices of the major wholesaler for each year from

2001 - 2004, where such data are available.

57. Defendants have similarly illegally and deceptively misrepresented and

inflated the wholesale acquisition cost ("WAC) of their drugs making it appear that any

reduction in the purchase price beyond the listed WAC would result in a loss to the

wholesaler and was, hence, unachievable, when in fact the WAC was secretly

discounted by the Defendants to purchasers other than the Medicaid and Medicare

programs through an elaborate charge back system.

IV. DEFENDANTS' EXACERBATION OF THE COMPLEXITIES OF THE MARKET AND AFFIRMATIVE CONCEALMENT OF THEIR WRONGDOING

58. Defendants have been able to succeed in their drug pricing scheme for

more than a decade by exacerbating the complexities of the incredibly huge, and

dauntingly complex, drug market, and by purposely concealing their pricing scheme

from Hawaii and other payers, as set forth below.

59. The published wholesale price of the thousands of NDC numbered drugs

may, and often does, change at any time. As a consequence, just to track the current

published prices of drugs utilized by a state's citizen requires resources and expertise

that Hawaii and most other states do not have.

60. Defendants have further exacerbated the inherent complexities of the drug

market by utilizing marketing schemes that conceal the true price of their drugs in the

following different ways.

61. First, Defendants sell their drugs in a unique manner that hides the true

price of their drugs. This scheme works as follows. Upon agreeing on a quantity and

price of a drug with a provider, or group of providers, the Defendants purport to sell the

agreed upon drugs to wholesalers with whom they have a contractual arrangement, at a

price they call the Wholesale Acquisition Cost ("WAC). The WAC may be higher than

the price agreed upon by the provider and the drug manufacturer. The wholesaler then

ships the product to the provider, charging the provider the (lower) price originally

agreed upon by the drug manufacturer and the provider. When the wholesaler receives

payment from the provider, it charges the manufacturer for the difference between the

price agreed-to between the manufacturer and the provider and the WAC, and sends a

bill to the manufacturer, called a "charge back," for the difference between the WAC and

the price actually paid by the provider. These charge backs, (or shelf adjustments, or

other economic inducements) are kept secret, so that it appears that the wholesaler

actually purchased the drug at the higher WAC price. The effect of this practice is to

create the impression that the "wholesale price" of the drug is higher than it really is.

Defendants hide other actual price reductions by directly paying providers market share

rebates that are calculated long after the actual provider dates of the drugs.

62. Second, Defendants further inhibit the ability of Hawaii and other ultimate

purchasers to learn the true cost of their drugs by wrapping the sales agreements they

negotiate with providers in absolute secrecy, terming them trade secrets and

proprietary, to preclude providers from telling others the actual price they paid.

63. Third, Defendants further obscure their true prices for their drugs with their

policy of treating different so-called classes of trade differently. Thus, for the same

drug, pharmacies are given one price, hospitals another and doctors yet another.

64. Fourth, some Defendants have hidden their real drug prices by providing

free drugs and phony grants to providers as a further means of discounting the overall

price of their drugs. For example, Defendant TAP pled guilty to a federal criminal

indictment for engaging in such conduct and paid $875 million in fines and damage, and

Defendant AstraZeneca paid $355 million to settle federal fraud charges that it induced

doctors to falsely bill Medicare and Medicaid..

65. Defendants have hidden their motives for utilizing an inflated AWP from

the public. Indeed, one official, a high ranking employee of Dey, even went so far as to

lie under oath about Dey's marketing of its spread. Only with the disclosure of materials

secured by litigants in recent discovery has it become apparent that one reason

Defendants were intentionally manipulating the nation's drug reimbursement system

was to compete for market share on the basis of a phony price spread, instead of the

true selling price of their drugs or the medicinal efficacy of these drugs to their users.

66. Defendants have further concealed their conduct by making sure that all of

the entities purchasing drugs directly from the Defendants (and, hence, knowledgeable

about the true price of their drugs) have had an incentive to keep Defendants' scheme

secret. Defendants' scheme permits all providers, pharmacies, physicians, and

hospitalslclinics, to make some profit off of Defendants' inflated spread, because they

are all reimbursed in some manner on the basis of the AWP for at least some of the

drugs they sell or administer. For providers, therefore, the greater the difference

between the actual price and the reported AWP, the more money they make. Thus,

providers willingly sign drug sales contracts requiring them to maintain secrecy about

the prices they pay for drugs.

67. Defendants have continuously concealed the true price of their drugs and

continued to publish deceptive AWPs and WACS as if they were real, representative

prices. Indeed, in the 2000 Edition of Novartis' Pharmacy Benefit Report, an industry

trade publication, the glossary defines AWP as follows:

Average wholesale price (AWP) - A published suggested wholesale price for a drug, based on the average cost of the drug to a pharmacy from representative sample of drug wholesalers. There are many AWPs available within the industry, AWP is often used by pharmacies to price prescriptions. Health plans also use AWP - usually discounted - as the basis for reimbursement of covered medications.

IVovarfis Pharmacy Benefit Report: Facts and Figures, 2000 Edition, East Hanover,

NJ, Novartis Pharmaceuticals Corporation, p. 43.

68. Defendants' unlawful scheme has completely corrupted the market for

prescription drugs. Instead of competing on prices and medicinal value alone, the

Defendants have deliberately sought to create a powerful financial incentive for

providers to prescribe drugs based primarily on the spread between the true price of a

drug and its published AWP or WAC. Creating incentives for providers to prescribe

drugs based on such a spread is inconsistent not only with Hawaii statutes, but also its

public policy. Large price spreads on higher priced drugs encourage providers to

prescribe more expensive drugs instead of their lower priced substitutes thereby

increasing the cost of healthcare, and competition on the basis of such spreads has the

potential to influence (consciously or unconsciously) providers to prescribe less

efficacious drugs over ones with greater medicinal value. Because of Defendants'

concealment of their scheme, Hawaii and its citizens have unknowingly underwritten

this perversion of competition in the drug market. In sum, Defendants have been, and

continue to be, engaged in an insidious, deceptive scheme that is causing Hawaii and

its citizens to pay scores of millions of dollars a year more than they should for their

prescription drugs, and may well be inducing some providers to prescribe less

efficacious drugs.

V. THE GOVERNMENTAL INVESTIGATIONS OF DEFENDANTS' CONDUCT

69. The first governmental investigation of Defendants' conduct began in 1995

when a small infusion pharmacy, Ven-a-Care of the Florida Keys, filed sealed qui tam

actions with the Federal Government and in Texas, Florida, California and Illinois alleging

that certain Defendants were intentionally inflating the reported AWPs of certain drugs,

primarily physician administered drugs,

70. In 1997, in response to the Ven-a-Care Complaint, the Federal Government

issued subpoenas to certain of the Defendants including Dey, Abbott and Warrick seeking

pricing information from them.

71. In 2000, Congress began its investigation of the pricing practices of some of

the Defendants in connection with the Medicare Part B program based on the materials it

received through its subpoenas. As part of this investigation U.S. Representative Pete

Stark, on September 28, 2000, wrote to the President of the Pharmaceutical Research and

Manufacturers of America (of which most of the Defendants are members) as follows:

Drug company deception costs federal and state governments, private insurers and others billions of dollars per year in excessive drug costs. This corruptive scheme is perverting the financial integrity of the Medicare program and harming beneficiaries who are required to pay 20% of Medicare's current limited drug benefit. Furthermore, these deceptive, unlawful practices have a devastating financial impact upon the states' Medicaid Program.. . .

The evidence I have obtained indicates that at least some of your members have knowingly and deliberately falsely inflated their representations of the average wholesale price YAWP"), wholesaler acquisition cost ("WAC) and direct price ("DP") which are utilized by the Medicare' and Medicaid programs in establishing drug reimbursements to providers. The evidence

clearly establishes and exposes the drug manufacturers themselves that were the direct and sometimes indirect sources of the fraudulent misrepresentation of prices. Moreover, this unscrupulous "cartel" of companies has gone to extreme lengths to "mask" their drugs' true prices and their fraudulent conduct from federal and state authorities. I have learned that the difference between the falsely inflated representations of AWP and WAC versus the true prices providers are paying is regularly referred to in your industry as "the spread." . . .

The evidence is overwhelming that this "spread" did not occur accidentally but is the product of conscious and fully informed business decisions by certain PhRMA members ... .

146 Cong. Rec. El622 (daily ed. September 28, 2000) (September 28, 2000 letter from

House Committee on Ways and Means, Subcommittee on Health, to Alan F. Holmer,

President, Pharmaceutical Research and Manufacturers of America, Washington, D.C

72. On December 21,2000, Congress passed the Medicare, Medicaid and

SCHlP Benefits Improvement and Protection Act of 2000 ("BIPA"), Pub. L. No. 106-554, §

429(c) (2000) which required a comprehensive study of drug pricing

73. Continuing Congress' investigation of Medicare Part B pricing in 2001

Congressman Stark wrote to Defendant Bristol-Myers on February 22, 2001 outlining

numerous apparent illegal pricing practices:

The evidence clearly shows that Bristol has intentionally reported inflated prices and has engaged in other improper business practices in order to cause its customers to receive windfall profits from Medicare and Medicaid when submitting claims for certain drugs. The evidence further reveals that Bristol manipulated prices for the express purpose of expanding sales and increasing market share of certain drugs where the arranging of a financial benefit or inducement would influence the decisions of healthcare providers submitting the Medicare and Medicaid claims.

147 Cong. Rec. E244-45 (daily ed. February 28, 2001).

74. In 2003, the House Committee on Energy and Commerce expanded

Congress' Medicare investigation into pricing practices in the state Medicaid program. On

June 26, 2003, Chairman Billy Tauzin (R.-La.) and Oversight and Investigations

Subcommittee Chairman James Greenwood (R.-Pa.) wrote as follows to 26 drug

companies, including many of the Defendants here:

The Committee on Energy and Commerce is conducting an investigation into pharmaceutical reimbursements and rebates under Medicaid. This inquiry builds upon the earlier work by this Committee on the relationship between the drug pricing practices of certain pharmaceutical companies and reimbursements rates under the Medicare program. In that investigation, the Committee uncovered significant discrepancies between what some pharmaceutical companies charged providers for certain drugs and what Medicare then reimbursed those providers for dispensing those drugs. This price difference resulted in profit incentives for providers to use the drugs of specific companies as well as higher costs to the Medicare system and the patients it serves. For example, we learned that one manufacturers sold a chemotherapy drug to a health care provider for $7.50, when the reported price for Medicare was $740. The taxpayer therefore reimbursed the doctor almost $600 for dispensing the drug and the cancer patient had a $148 co- payment. Such practices are unacceptable in the view of the Committee, which is why we are in the process of moving legislation to address these abuses.

The Committee has similar concerns regarding drug prices in Medicaid, which has a substantially larger pharmaceutical benefit than Medicare.

House Committee on Energy and Commerce Press Release, Tauzin, Greenwood Expand

Medicaid Fraud Investigation (June 26, 2003) at http://energycommerce.house.govl

75. This investigation is continuing. On December 7, 2004, the House

Subcommittee of Oversight and Investigation of the Commerce and Energy Committee

conducted a hearing on "Medicaid Prescription Drug Reimbursement: Why the

Government Pays Too Much." In his opening remarks, Chairman Joe Barton (R-TX)

stated:

Data obtained by the committee from five of the largest retail pharmacy chains reveals that during the period of July I, 2002 to June 20, 2003, the average acquisition costs for seven widely prescribed generic drugs was 22 cents, while the average Medicaid reimbursement just for those drugs alone was 56 cents, more than double the cost . . . .

Medicaid Prescription Drug Reimbursement: Why the Government Pays Too Much:

Hearing Before the House Subcomm. on Oversight and Investigations, No. 108-126, at 5

(2004) available at http://f~ebgate.access.gpo.govlcgi-binluseftp.cgi?lPaddress=

(opening statement of Joe Barton, Chairman, House Subcomm. on Oversight and

Investigations).

76. The importance to Hawaii and the other states of the information being

sought by this investigation was explained by Henry Waxman during the December 2004

House Committee on Energy and Commerce hearings on Medicaid pricing practices,

Congressman Waxman explained that even though the federal government had access to

the manufacturers' actual average manufacturers prices ("AMPS"), the states did not:

the drug industry was powerful, and they succeeded in securing a provision in the basic legislation that kept the Best Price and the AMP information a secret. Can you imagine that? The federal qovernment knew this information, but we k e ~ t it a secret from the states. This has proved to be a costly error. Without this crucial piece of information, states who were, afler all, responsible for establishing the reimbursement rate for prescription drugs could not set their reimbursement rates appropriately. As a result, [the states] continued to rely on the average wholesale price minus the arbitrary amount because they did not have the information needed to set a more appropriate reimbursement rate.

Id. at 23. (Emphasis added).

77. Concomitant with Congress' investigation, the United States Department of

Justice and the National Association of Medicaid Fraud Control Units (NAMFCU)

conducted their own much more limited investigation into 400 of the 50,000 NDC numbers

state Medicaid programs reimbursed in 2000 concluding that some drug manufacturers

were reporting inflated average wholesale prices for certain of these drugs.

78. As a result of all these investigations many states began to investigate on

their own Defendants' drug pricing practices leading to lawsuits in some 20 separate

states including Hawaii. Notwithstanding these investigations and lawsuits Defendants

continue to publish, or participate in the publication of, inflated wholesale prices and

continue to hide the true prices of their drugs including opposing discovery of the actual

prices of these drugs in litigation.

VI. THE INJURY TO GOVERNMENTAL HEALTH PLANS CAUSED BY DEFENDANTS' FALSE WHOLESALE PRICES

A. The Hawaii Medicaid Program

79. Medicaid is a joint federal and state health care entitlement program

authorized by federal law, with mandatory and optional provisions for eligibility and

benefits covered, including prescription drugs. Plaintiff State of Hawaii, via the

Department of Human Services ("DHS"), administers Hawaii's Medicaid program and

reimburses physicians and pharmacies for drugs prescribed for, and dispensed to,

Medicaid recipients. Hawaii Medicaid also pays the 20% co-payment for prescription

drugs for Hawaii Medicare beneficiaries who are also qualified to receive Medicaid

benefits.

80. In 2004 there were approximately 43,189 individual recipients of Hawaii's

Medicaid drug services. The cost of drug services in the Hawaii Medicaid program have

seen dramatic increases rising from slightly over $20.7 million in 1997 to slightly over

$1 12.5 million in 2004, an increase of over 500%.

81. In its report to the Legislature on Act 259, Part Ill, Section 39 Prescription

Drugs for Fee for Service Clients, the DHS reported expending $63,255,737 for

medication in calendar year 2000. There were approximately 35,000 eligible recipients.

In its report to the Twenty-Third Hawaii State Legislature in 2005, DHS reported that it

spent $1 12,575,993.82 for all prescription drugs in fiscal year 2004 in its Med-Quest

program.

82. Hawaii's Medicaid program provides services through various programs

such as the Fee-For-Service program that provides services to qualified persons who

are aged 65 and over, or certified blind or disabled under which payment is made

directly to the provider, and the Med-Quest program that provides coverage for all other

qualified persons under a managed care program.

83. With some exceptions, reimbursement to pharmacies and physicians for

drugs covered by the Hawaii Medicaid program is made at the AWP minus a percentage

(currently 10.5%), plus a dispensing fee.

84. For a minority of the drugs purchased by Hawaii, the state sets its

reimbursement rate at either the Federal Upper Limit ("FUL") or at a rate established by

the State Maximum Acquisition Cost ("SMAC") Program. For multi-source drugs that have

at least three suppliers, the Center for Medicaid Services ("CMS") generally establishes

federal upper limits of FULs, defined as 150% of the least costly therapeutic equivalent

(using all national compendia) that can be purchased by pharmacies in quantities of I00

tablets or capsule or, in the case of liquids, the commonly listed size. 42 C.F.R. § 447.332.

As a practical matter CMS relies on the published AWPs to set most of its FULs. The

states may also set reimbursement rates for these drugs at rates lower than the FUL

pursuant to the State SMAC program and Hawaii has done so in a number of instances.

85. At all relevant times, each Defendant was aware of Hawaii's Medicaid

reimbursement formulas and Hawaii's reliance on the Defendants reported AWPs.

86. By publishing false and inflated wholesale prices, and by keeping their true

wholesale prices secret, Defendants have knowingly enabled providers of drugs to

Medicaid recipients to charge Hawaii false and inflated prices for these drugs, and

interfered with Hawaii's ability to set reasonable reimbursement rates for these drugs. As

a consequence, Hawaii's Medicaid program has paid more for prescription drugs than it

would have paid if Defendants had published their true wholesale prices.

B. The Medicare Program

87. Medicare is a health insurance program created by the federal

government for the elderly and disabled and other eligible persons. 42 U.S.C. 1395, et.

seq. Typically, individuals become eligible for Medicare health insurance benefits if they

are over 65 years of age, disabled, or have end stage renal disease. There are two

major components of the Medicare Program, Part A and Part B.

88. Medicare Part B is an optional program that provides coverage for some

healthcare services for Hawaii's participating elderly and disabled citizens not covered

by Part A. 42 U.S.C. 13951 through 1395w-4. Medicare Part B is supported by

government funds and premiums paid by eligible individuals who choose to participate

in the program.

89. At issue here is Medicare Part B's limited benefit for drugs which are

provided either: (a) incident to a physician's service and cannot generally be self-

administered; or (b) in conjunction with the medical necessity of an infusion pump or

nebulizer or other durable medical device payable under Medicare's DME benefit

equipment ("DME).

90. In order to calculate the portion Medicare recipients must pay for Part B

benefits, the Medicare program has looked to the falsely-reported AWPs. The starting

point is the calculation of the "allowable cost." From 1992 until 1997, the methodology

for calculating the allowable cost of Medicare Part B drugs was 100% of the published

AWP. From 1997 until January I , 2004, the methodology for calculating the allowable

cost of brand name (single-source) drugs was 95% of the published AWP. During this

same time period, for multiple-source drugs, the allowable cost was calculated as 95%

of the lower of (a) the median AWP for all sources of the generic forms of the drug or (b)

the lowest brand-name product AWP. 42 C.F.R. s405.517. From January I , 2004 until

January I, 2005, the methodology for calculating the allowable cost was 85% of the

published AWP. Medicare pays 80% of the allowable cost. The remaining 20% is paid

as a co-payment by the Medicare Part B beneficiary, or for individuals eligible for

Medicaid (known as "dual eligibles"), by the Medicaid program. In addition, Medicare

Part B beneficiaries are required to pay an annual deductible amount before Part B

benefits are payable.

91. Because Medicare Part B participants must pay 20 percent of the

allowable cost, which is based on the AWP, for their medications, and because

Defendants have published false and inflated AWPs for their drugs, Medicare Part B

participants are paying substantially more for their co-pay than they would pay if

Defendants published their true wholesale prices. Indeed, with respect to some drugs,

the 20% co-pay for the Medicare Part B participant is greater than the cost of the drug.

VII. DEFENDANTS' CONDUCT INTENTIONALLY DISREGARDED ESTABLISHED LAW

92. Defendants have a duty to deal completely honestly with the State of

Hawaii and they know it.

93. Moreover, it is long-settled law that it is unlawful for a seller to cause to be

circulated a price at which no, or few, sales are actually expected, whether it is called a

list price, suggested price, or benchmark price. E.g., FTC v. Colgafe-Palmolive Co.,

380 U.S. 372 (1965); FTC v. The Crescent Publishing Group, Inc., 129 F. Supp.2d 31 I

(S.D.N.Y. 2001). Defendants either knew of this law or acted in reckless and conscious

disregard of it.

94. Congressional hearings have excoriated the pharmaceutical industry for

causing untrue AWPs to be published.

95. Defendants have violated their duty to Hawaii and its citizens by

intentionally misrepresenting their reported prices. By manipulating the AWP and

keeping secret the true AWP, Defendant Drug Manufacturers inflated the prescription

drug prices thus causing Hawaii and its citizens to overpay for their drug purchases.

VIII. TOLLING

96. Any applicable statute of limitation has been tolled by Defendants'

knowing and active concealment and or as a continuing violation. Because of their

knowing, affirmative, andlor active concealment of the fraudulent nature of the

published AWPs, Defendants are estopped from relying on any statutes of limitations.

Count 1 - False Claims

(On Behalf of the State of Hawaii)

97. Defendant Drug Manufacturers knowingly caused to be presented to an

officer or employee of the State a false or fraudulent claim for payment, and/or caused

to be made or used a false record or statement andlor conspired to defraud the State by

getting a false or fraudulent claim allowed or paid in violation of H.R.S. 5 661-21 (a)(l),

(2) and (3).

Count 8 1 - Unfair or Deceptive Acts or Practices

(On Behalf of Hawaii Medicare Beneficiaries and State of Hawaii)

98. Plaintiff re-alleges and incorporates all the above allegations.

99. The AWP scheme constitutes an unfair or deceptive act or practice in

violation of Chapter 480, H.R.S.

H.R.S. § 480-2 provides in part:

(a) Unfair methods of competition and unfair or deceptive acts or practices in the conduct of any trade or commerce are unlawful

100. Defendants violated this section by, including but not limited to,

intentionally engaging in a scheme to falsify the true AWP of their drugs, reporting false,

misleading and inflated pricing information on their drugs to national reporting services

while at the same time concealing actual AWP pricing information. The reporting

services in turn published the Defendants' inflated pricing information to substantial

numbers of persons, including but not limited to, the MedicareIMedicaid program, in

connection with the promotion of the sale of, or to increase the consumption of,

Defendants' prescription drugs. This conduct caused the beneficiaries to overpay, and

allowed Defendants to increase their market share.

Count 118 - Unfair Competition

(On Behalf of Medicare Beneficiaries and the State of Hawaii)

101. Plaintiff re-alleges and incorporates all the above allegations.

102. The AWP Scheme constitutes an unfair competition act in violation of

Chapter 480, Hawaii Revised Statutes.

103. Defendants violated this section by, including but not limited to,

intentionally engaging in a scheme to falsify the true AWP of their drugs, reporting false,

misleading and inflated pricing information on their drugs to national reporting services

while at the same time concealing actual AWP pricing information. The reporting

services in turn published the Defendants' inflated pricing information to substantial

numbers of persons, including but not limited to, the MedicarelMedicaid program, in

connection with the promotion of the sale of, or to increase the consumption. This

conduct caused the beneficiaries and the State to overpay, and allowed defendants to

increase their market share.

Count IV - Deceptive Trade Practices Act

(On Behalf of Medicare Beneficiaries and the State of Hawaii)

104. Plaintiff re-alleges and incorporates all the above allegations.

105. H.R.S. 3 481A-3 provides:

(a) A person engages in a deceptive trade practice when, in the course of the person's business, vocation, or occupation, the person:

(9) Advertises goods or services with the intent not to sell them as advertised;

(1 1) Makes false or misleading statements of fact concerning the reasons for, existence of, or amounts of price reductions;

(12) Engages in any other conduct that similarly creates a likelihood of confusion or misunderstanding.

106. Defendants violated these sections and thereby committed a per se

violation of H.R.S. § 480-2 by, including but not limited to, intentionally engaging in a

scheme to falsify the true AWP of their drugs, reporting false, misleading and inflated

pricing information on their drugs to national reporting services while at the same time

concealing actual AWP pricing information. The reporting services in turn published the

Defendants' inflated pricing information to substantial numbers of persons, including but

not limited to, the MedicarelMedicaid program, in connection with the promotion of the

sale of or to increase the consumption of Defendants' prescription drugs and thereby

caused Hawaii and its citizens to overpay for Defendants' drugs.

Count V - Intentional and I or Neqliqent Misrepresentation

(On Behalf of the State of Hawaii)

107. Plaintiff re-alleges and incorporates all the above allegations.

108. Defendants intentionally andlor negligently caused to be published false

and incorrect pricing information, as described above, in trade publications.

109. Defendants engaged in this scheme with the intent that others, including

the State of Hawaii's Medicaid Program, use it in their business transactions.

11 0. Plaintiff State of Hawaii's Medicaid Program relied upon the false and

incorrect AWP information, as alleged above, and was damaged by overpaying for

Defendants' drug products.

Count VI - Unjust Enrichment

(On Behalf of Medicare Beneficiaries and the State of Hawaii)

11 1. Plaintiff re-alleges and incorporates all the above allegations.

112. Defendant Drug Manufacturers knew that pharmacies and physicians who

obtained MedicareIMedicaid reimbursement for Defendants' drug products were not

entitled to improperly inflated reimbursement rates that were based on Defendants'

false pricing information.

113. As a result of the excessive payments to health care providers of all or

part of the "spread," Defendants were unjustly enriched at the expense of the State of

Hawaii and its citizens.

114. Defendants knew they were not entitled to the profits that resulted from

the sales obtained through the use of the spreads they created, and should be required

to make restitution of all such amounts obtained through the use of such spreads.

WHEREFORE, Plaintiff and the Attorney General on behalf of its citizens, ask the

Court for the following relief and seek judgment against the Defendant Drug

Manufacturers as follows:

a. That general and special damages be awarded to the State of Hawaii and

Hawaii Medicare beneficiaries.

b. That mandatory treble damages be awarded pursuant to H.R.S. §§ 480-

13, 480-14, 661-21 or alternatively punitive damages.

c. That qualifying Medicare beneficiaries be awarded the statutory minimum

damages of $5,000 per incident for unfair and deceptive acts and practices against

elderly persons pursuant to H.R.S.§ 480-13(b).

d. That the Court award costs of suit, pre-judgment and post-judgment

interest, and attorneys' fees pursuant to H.R.S.§ 480-13 and 480-14, 661-21 or as

otherwise allowed by law; and such other relief as this Court deems just and proper.

e. That the Court assesses civil penalties pursuant to H.R.S. § 480-13.5 or

661-21 or as otherwise allowed by law.

f. That the Court enjoins the Defendant Drug Manufacturers from continuing

the deceptive or unfair acts or practices complained of herein

g. That the Court grants such other and further relief or equitable relief that it

deems just and proper

Dated: Honolulu, Hawaii, Jut 3 - 2007

CHARLES BARNHILL, JR. SPECIAL DEPUTY ATTORNEY GENERAL

GEORGE F. GALLAND, JR. ROBERT S. LIBMAN W. DANIEL "Dee" MILES, Ill CLINTON C. CARTER P. JEFFREY ARCHIBALD MICHAEL WINGET-HERNANDEZ WARREN PRICE, Ill KENNETH T. OKAMOTO

ATTORNEYS FOR PLAINTIFF

STATE OF HAWAII v. ABBOTT LABORATORIES INC., et al.; Civil No. 06-1-0720-04 EEH; Second Amended Complaint

VOL 6 IKJ 0

How Drugs are Purchased

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nrst P~tl\hnk, whbluslors~rv&;~; u ~ d ~ f i a l o r ~ o r c u P n ~ : toutabllrh bn ::;j, Avcr~gsWhd~sde Rlce ( A T m u h p ~QY.:..

,anpw com~my thatdoun< ~roHd.en.i?::

S u ~ e s l a d ~ d ~ a l c ~ f i t ~ rmflrm thbt the r n u k ~ p ths! ~ ~ w : t o Flrsl Dhlhgank. .* ' u ~ l l r u $rAWlr rcprerentatlvcclthe r : who\p.qllcrlndua~ry. Asumeymay be . .. pvlormed an aalngla h3c n m b b ar I&-.. mmufbchiFtZd canre line [email protected]$~: ~liheichchr+ ' 6 . ~ h ' w h o ' ~ ~ ~ l 6 cuwtytd ~hi number01 produclc !44thln each m&h~laflj$: el. . ,, ,.

Thcnumbcr or survaya perfirmed II : : mcrcsrlng, nr~lDatDBank suweyr at mlnl.' i m u m livd dng whofnsaler that reptelen!:,$,

twdh'rds Of thetptaldPl'*~~'umf:Q~: dNswhderdeni,.mcm~up that F!fst~$ DatQapkuUlb le rtprrsentativaor*:fi.~! whbtuluslrrs onbnntlonol leutl. Beeaura . Ind~dutlwholcddcrs may mwkupeach ..'f m ~ u ~ ~ ~ N t e r d ~ ~ e ~ ~ n t ~ ~ ~ h w t l ~ h t e d e ~ u ~ f , , no! a.con8emurwbrre, !sc~culsre%Thc!, . i8,thb marlnlrhire hcld bythewhvhglec4brb.. sumyed afiechthe rnulplp ~roportpn~yz~

ngura 2 - ~ ~ C E ~ D W to conntantly remind manulhcturen h h t thelr prldng must be supplltd on tlme, Wllh the adqenf of on-line rlalmspmcessl~g. prlcln~rn\,stbe lhere when the update DCCUrt! Some manuf8ctureri, do re!ea)c$hcir priceupdates until the elf$~[l~~~$~!$.~b,%al purehaserc c & h b t t a & e ~ p p p & n \ t y o f p < ~ ~ < ~ ~ i ~ ~ $ j ~ ~ o ~ d P ; ~ I C ~ J U ~ ~ l>etore th~.!I~$$Wo have madean all+Ut. effortlqppp~!se the manuhcturera of our.dgad!ip'ts q~ that they do not miss the monthly~chedule We art bbegi$!!& t? see I'&S~lt8 in lhi$ ei10rt.

D @ ~ C ~ U ! & ~ I I Q ~ 18 adllflcult, ex!~t!hi iaskwhlth reQultB c o n ~ ~ ~ . n ~ vlgll{n~~!. Reporting AWP Is an Impblf~ntfunclloh olFlrrt DhtaRattk

dwptake this respansiblllry :fipmly.

.

Whdcsalers wlth hlghtr d ~ g dollu~wluip~ i hsvrinvr~ wtl~ht In lhedetermlnaflon dfh!,, flnalmukup. Tnur, dhlshar degree'bl j.!:3. ce~alnly lr schltvtd. ..:

bmostwes, thcruul; !romsu*$; btch whkt hrt h l h k b whit. In !\h%.

&tdncn that do not. 11 1s wily thu~~:?. 'lp' DdhBMku'll Ch4nf"he m ' r k ~ ~ ? ~ & i lo repmt markctplacl rad1i-f. ..: ::z

u s u a ~ ~ y r e s u l ~ s when two companles merge lnlb a ~ l n g l e entity, Steking t o merge two priclng methcds into a unlfled whole, some products arhlblt . an AW drop.

Pharmacler holding invknlprler of thest product$ hall expected to sell thelr.Ipvehlofy b ~ e d on current o r ,

tutweAWP. Consequently, when ~,lllligthl~d p a r ~ e n at AWP, t h i $ t m ~ on hand will produce lets prollt than expecled,

The accounting method mast commpnly used 16 to car iy i n v e n t o t ~ ~ a t . the ]o,ver of cost o r market value, The sellbgprife dpes not enter lnto the plctdreurtlll the product Is-actually $old. U the selllng prlce decreases bel0w&&l cost, then the harrying value drops correspondtngly. Converaely,II the gelling price d m not

Pn'cgDesllne,s And Balann! ,

Sheet6 &th~uglr t!,oexpecled movnment

f A%'&$ upwnrd, there Is nn LCBJlgDe) dbdhleWlthD~t a corre,p~n$fng dlange In whoIe8~le net 31 dIroc\ prlcta. Such sn Mcuncnce

decreas'ebelow actual cost, then the cariylng valve does npt drop, bul the ellecls arelelt In luture cash flow and prolltablllty.

&long a6 mergers and hcqulsltl~ns conHnue in the phar~aceutlcal Industry, we can txpecl oiCaslonal IWP decreares.

thklthc AWP rellocb reality.

. -7.- s-- , - --

Arkansas Prior Au\h~.r;!aLicln bbs' markup, (See page one lor a (ARIPA) ~s now avaiiabl~ :r,ljr

dbcusslon ol rnarkllps.) However, Cor~ard slill has &n

NDC number recag,~lzable In the industry G a Squlbb producl, 1.e. It has e labtler code of 00003. Allhoufn the ~w=------ distributor chhnged,~nd thy6 the AWP, the NDC nu;n>er remalned the Colorado Meclicald same. Slnce any pbrtlcular labeler : Colorado Prior Au!l~orirallon rdll be codeis no longer strictly associated changed IromC-2 drl~n~ls>ii , 1:. ".? wilh only one dlstribulor, No dellnltlons. The new PA cod? ; .' producb with t h e same lsbeler luay have AWP's calculertd trom lotally 3 ,I Prlor authoriz~riorr ii r tqu~red il dlllerent markups. drug l r dlspensed lhrough an

Although the,occaslonal outpatlent pharmacy.

Exhibit "2"

G&-,&jcftb tbv A@ ds md paid on t pwkmzh

'phe &&e dele for fhLs 0 Is September % Z M .

a e tmpbecrla8~n6ate @P Qtb PM6n Sspten~ber @, 20D.

T a e btm&on?i $AD@& be ImpIernW &bb your ummtoperailng 6ttd&

Tble PM mey be disarnepd Sepkmba I, 2001.

Epw bnv* myq~e#hlu mutad Rabat Mem&u0 st 4lMW531.

4 ,+.Wchrnent I - IF you deiide to vie ihese data, use solely these duto to updofa the I-ICPCS biling codes fhol correspond to The drugs on this list.

Aitochrn~nt 2- Do E! use these data to update the HCPCS bilAng codes that cokspond to the dNgs on this DsBsl. Inrfiod, use your vmol source for uveroge wholesois prices.

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IN THE CIRCUIT COURT OF THE FIRST CIRCUIT

STATE OF HAWAI'I

State of Hawaii,

Plaintiff,

VS.

Abbott Laboratories Inc.; Alpharma USPD, Inc.; Apothecon, Inc.; AstraZeneca Pharmaceuticals LP, AstraZeneca LP; Aventis Pharmaceuticals, Inc.; Aventis Behring LLC nlkla ZLB Behring LLC; Barr Laboratories, Inc.; Baxter Healthcare Corporation; Ben Venue Laboratories, Inc.; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer lngelheim Roxane, Inc. flWa Roxane Laboratories, Inc.; Bristol- Myers Squibb Co.; Centocor, Inc.; Dey, Inc.; Forest Pharmaceuticals, Inc.; SmithKline Beecham Corporation dlbla GlaxoSmithKline; Hoffman-LaRoche, Inc.; Hospira, Inc.; lvax Corporation; lvax Pharmaceuticals Inc.; Janssen, LP flMa Janssen Pharmaceutica, LP; Johnson & Johnson, Inc.; McNeil-PPC, Inc.; Merck & Co., Inc.; Mylan Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Ortho Biotech Products, LP; Par Pharmaceutical Cos., Inc.; Pfizer, Inc.; Pharmacia Corporation; Purepac Pharmaceutical Co.; Roche Laboratories, lnc.; Sandoz, Inc.; Schering-Plough Corporation; Sicor Pharmaceuticals, Inc. flkla Gensia Sicor Pharmaceuticals, Inc.; TAP Pharmaceutical Products, Inc.; Teva Pharmaceuticals USA, Inc.; Warrick Pharmaceuticals Corporation; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc., flWa Schein Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Doe Corporations 1-1 00; Doe Eniities 1-100.

Defendants.

Civil No. 06-1-0720-04 EEH (Complex Litigation)

SUMMONS TO ANSWER SECOND AMENDED COMPLAINT

SUMMONS TO ANSWER SECOND AMENDED COMPLAINT

STATE OF HAWAII

To the above-named Defendants:

You are hereby summoned and required to serve upon Plaintiff's attorney, Price,

Okamoto, Himeno & Lum, whose address is 707 Richards Street, Suite 728, Honolulu,

Hawaii 96813, an answer to the Second Amended Complaint, which is attached. This

action must be taken within twenty (20) days after service of this summons upon you,

exclusive of the day of service.

If you fail to make your answer within the twenty (20) day time limit, judgment by

default will be taken against you for the relief demanded in the Complaint.

This summons shall not be personally delivered between 10:OO p.m. and 6:00

a.m. on premises not open to the general public, unless a judge of the above-entitled

court permits, in writing on this summons, personal delivery during those hours.

A failure to obey this summons may result in an entry of default and default

judgment against the disobeying person or party.

DATED: Honolulu, Hawaii

STATE OF HAWAII v. ABBOTT LABORATORIES, et al.; Civil No. 06-1-0720-04 EEH; Summons t o Answer Second Amended Complaint

. - . ,. . .. , .. . .... .. ,.. , . .. In accordance.with the Arilericans with Disabilities Act, and other applicable state

and federal laws, if you require a rexonable accommodation for a disability, please contact the ADA Coordinator at the First Circuit Court Administration Office at PHONE YO. 539-4333, FAX 539-4322, or TIY 539-4853, at least ten (10) working

. . . . . ... . . . . .... . . days prior to your hearing or appointment date.

IN THE CIRCUIT COURT OF THE FIRST CIRCUIT

STATE OF HAWAI'I

State of Hawaii,

Plaintiff,

Abbott Laboratories Inc.; Alpharma USPD, Inc.; Apothecon, Inc.; AstraZeneca Pharmaceuticals LP, AstraZeneca LP; Aventis Pharmaceuticals, Inc.; Aventis Behring LLC n/Wa ZLB Behring LLC; Barr Laboratories, Inc.; Baxter Healthcare Corporation; Ben Venue Laboratories, Inc.; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer lngelheim Roxane, Inc. flWa Roxane Laboratories, Inc.; Bristol- Myers Squibb Co.; Centocor, Inc.; Dey, Inc.; Forest Pharmaceuticals, Inc.; SmithKline Beecham Corporation dlbla GlaxoSmithKline; Hoffman-LaRoche, Inc.; Hospira, Inc.; lvax Corporation; lvax Pharmaceuticals Inc.; Janssen, LP Wkla Janssen Pharmaceutica, LP; Johnson & Johnson, Inc.; McNeil-PPC, Inc.; Merck & Co., Inc.; Mylan Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Ortho Biotech Products, LP; Par Pharmaceutical Cos., Inc.; Pfizer, Inc.; Pharmacia Corporation; Purepac Pharmaceutical Co.; Roche Laboratories, Inc.; Sandoz, Inc.; Schering-Plough Corporation; Sicor Pharmaceuticals, Inc. flkla Gensia Sicor Pharmaceuticals, Inc.; TAP Pharmaceutical Products, Inc.; Teva Pharmaceuticals USA, Inc.; Warrick Pharmaceuticals Corporation; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc., f/Wa Schein Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Doe Corporations 1-100; Doe Entities 1-100.

Civil No. 06-1-0720-04 EEH (Complex Litigation)

DEMAND FOR JURY TRIAL

Defendants.

DEMAND FOR JURY TRIAL

Plaintiff State of Hawaii, through its counsel, Price Okamoto Himeno & Lum,

hereby demands a jury trial on all claims in this action that are triable of right by a jury.

Dated: Honolulu, Hawaii, 'JUl 3 -' 2flgl

ATTORNEY F.& PLAINTIFF

CHARLES BARNHILL, JR. SPECIAL DEPUTY ATTORNEY GENERAL

GEORGE F. GALLAND, JR. ROBERT S. LIBMAN W. DANIEL "Dee" MILES, Ill CLINTON C. CARTER P. JEFFREY ARCHIBALD MICHAEL WINGET-HERNANDEZ WARREN PRICE, Ill KENNETH T. OKAMOTO

ATTORNEYS FOR PLAINTIFF

IN THE CIRCUIT COURT OF THE FIRST CIRCUIT

STATE OF HAWAI'I

State of Hawaii,

Plaintiff,

VS.

Abbott Laboratories Inc.; Alpharma USPD, Inc.; Apothecon, Inc.; AstraZeneca Pharmaceuticals LP, AstraZeneca LP; Aventis Pharmaceuticals, Inc.; Aventis Behring LLC nlMa ZLB Behring LLC; Barr Laboratories, Inc.; Baxter Healthcare Corporation; Ben Venue Laboratories, Inc.; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer lngelheim Roxane, Inc. f/k/a Roxane Laboratories, Inc.; Bristol- Myers Squibb Co.; Centocor, Inc.; Dey, Inc.; Forest Pharmaceuticals, Inc.; SmithKline Beecham Corporation dlbla GlaxoSmithKline; Hoffman-LaRoche, Inc.; Hospira, Inc.; lvax Corporation; lvax Pharmaceuticals Inc.; Janssen, LP f lua Janssen Pharmaceutica, LP; Johnson & Johnson, Inc.; McNeil-PPC, Inc.; Merck & Co., Inc.; Mylan Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Ortho Biotech Products, LP; Par Pharmaceutical Cos., Inc.; Pfizer, Inc.; Pharmacia Corporation; Purepac Pharmaceutical Co.; Roche Laboratories, Inc.; Sandoz, Inc.; Schering-Plough Corporation; Sicor Pharmaceuticals, Inc. flkla Gensia Sicor Pharmaceuticals, Inc.; TAP Pharmaceutical Products, Inc.; Teva Pharmaceuticals USA, Inc.; Warrick Pharmaceuticals Corporation; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc., flkla Schein Pharmaceuticals, Inc.; Watson Laboratories, lnc.; Doe Corporations 1-1 00; Doe Entities 1-1 00.

Civil No. 06-1-0720-04 EEH (Complex Litigation)

CERTIFICATE OF SERVICE

Defendants.

CERTIFICATE OF SERVICE

Pursuant to Case Management Order No. 1, entered by the Court in this case on

January 5,2007, the undersigned certifies that a copy of the SECOND AMENDED

COMPLAINT was served on all counsel of record through the LexisNexis File and Serve@

system on July 3, 2007

Dated: Honolulu, Hawaii, July 3. 2007,

pi-\ RICK J. E I ~ H ~ R

CHARLES BARNHILL, JR. SPECIAL DEPUTY ATTORNEY GENERAL

GEORGE F. GALLAND, JR. ROBERTS. LIBMAN W. DANIEL "Dee" MILES, Ill P. JEFFREY ARCHIBALD MICHAEL WINGET-HERNANDEZ WARREN PRICE, Ill KENNETH T. OKAMOTO

ATTORNEYS FOR PLAINTIFF